Implantable Repair Device

ABSTRACT

An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to implantable prosthesis, andmore particularly, to implantable prostheses having particularapplication for repairing and/or reinforcing an anatomical defect suchas a hernia.

2. Background Discussion

Various forms of implantable prostheses have been used for repairing orreinforcing tissue defects, such as soft tissue and muscle wall hernias.For example, it is well known to use an implantable fabric or mesh patchto cover the opening or defect. When an anterior approach is used forthe intra-peritoneal ventral hernia repair with a “blind” technique forplacing the patch, the patch must be collapsed for passage through theincision and defect, and subsequently released and expanded within theintra-peritoneal space. The patch must then be positioned appropriately,preferably as flat as possible, against the peritoneum. Typically, theside of the patch facing the viscera has tissue barrier characteristics,such as a barrier layer or film. The proper positioning of the patch,however, has proven to be difficult to do through the central accessincision in the defect.

More recently, at least one implantable prosthesis is known to include astrap or the like that is secured to a central location of the patch,and extends from the side of the patch that faces the abdominal wall outthrough the incision to the exterior of the patient's body. This deviceis described and illustrated in U.S. Pat. No. 7,101,381. The strapprovides a means by which to pull on the patch once it is inserted in aneffort to secure the patch against the parietal wall, thereby occludingthe defect. The strap is either sewn on or otherwise separately securedto the center of the patch, or is constructed in a manner that requirestwo separate portions to be secured to the patch as shown in FIG. 7 ofthe publication. Following final placement of the patch, the straps aresecured to adjacent fascia or muscle, such as by suturing, with anyexcess length being trimmed off.

With devices of this type, excess force exerted on the central portionof the patch by the straps can cause the patch to collapse centrally sothat the center of the patch begins to pass through the defect, with theradial portion of the patch buckling outwardly (away from the parietalwall) around it. This is extremely undesirable in that buckled orinverted edges expose the unprotected mesh material (portions without atissue barrier) directly to the internal viscera, increasing thelikelihood of undesirable attachments forming between the mesh and theviscera. Further, the securing of the straps to the central portion ofthe patch may in and of itself compromise the barrier layer. Thus, it isimportant in any such device to ensure that the patch remains positionedin a uniform plane against the viscera when pulling on the straps toposition it.

Although this type of device may incorporate a resilient peripheral“ring” to assist in returning the patch to the desired flatconfiguration following placement, this ring does not significantlyprevent the tendency to buckle as described above. Further, thedisclosed ring is comprised of a non-absorbable material, and thuspermanently leaves behind a substantial amount of material within thepatient. This can be particularly disadvantageous if the ring shouldever fracture, which could cause the rough fractured edge(s) to damagesurrounding tissue.

Accordingly, it is an object of the present invention to provideimproved implantable prostheses for repairing and/or reinforcing softtissue or muscle wall defects.

SUMMARY OF THE INVENTION

The present invention provides an implantable prosthesis for repairingor reinforcing a tissue or muscle wall defect including a firstbiocompatible structure having a central portion sized and shaped tocover at least a portion of the tissue or muscle wall defect and havinga top side, a bottom side, and first and second extension portionsextending laterally outward from opposite sides of the central portion.The prosthesis further includes a reinforcement element positionedadjacent the top side of the patch portion and having a top side, abottom side, and an outer circumferential edge, and a secondbiocompatible structure having a top side and a bottom side and at leastone opening therethrough, the at least one opening being substantiallycentrally located. The first and second extension portions of the firststructure extend about the outer circumferential edge of thereinforcement element and then inwardly along the top side of thereinforcement element between the reinforcement element and the secondstructure, to a central portion of the reinforcement element, and thenoutwardly from the central portion through the at least one opening inthe second structure. The first and second structures are furthersecured to one another at least about a peripheral edge of theprosthesis.

Also provided is an implantable prosthesis for repairing or reinforcinga tissue or muscle wall defect that includes a first composite structureincluding at least one layer of a non-absorbable material, where thefirst composite structure has a central portion sized and shaped tocover at least a portion of the tissue or muscle wall defect, and has anouter periphery. The prosthesis further includes a second structurehaving a reinforced central region and an outer peripheral edge, areinforcing element positioned between the first and second structures,and having an outer periphery and a stiffness greater than that of thefirst and second structures, and at least one pulling element coupled tothe reinforced central region of the second structure. The secondstructure is coupled to the first structure substantially only at theirrespective peripheries.

Finally, also provided is an implantable prosthesis for repairing orreinforcing a tissue or muscle wall defect including a firstsubstantially flat, flexible composite structure including at least onelayer of non-absorbable material, the first composite structure having acentral portion sized and shaped to cover at least a portion of thetissue or muscle wall defect and having an outer periphery, and a secondsubstantially flat, flexible, structure having an outer peripherysubstantially similar to the outer periphery of the first structure, andhaving a reinforced central region. The prosthesis further includes athree-dimensional reinforcing element positioned between the first andsecond structures and having an outer periphery substantially similar tothe outer periphery of the first and second structures, and at least onepulling element coupled to the central region of the second structure.The first composite structure and the second structure are coupled toone another substantially only around their respective outerperipheries.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of the components of a preferred embodimentof a prosthesis according to the present invention;

FIG. 1 a illustrates the prosthesis of FIG. 1 partially assembled;

FIGS. 2-5 illustrates the prosthesis of FIG. 1 at various points duringassembly;

FIG. 6 illustrates the prosthesis of FIG. 1 fully assembled;

FIGS. 7-8 are perspective and side views of the reinforcement element ofthe prosthesis of FIG. 1;

FIGS. 9-13 illustrate various steps of a procedure for implanting aprosthesis according to the present invention;

FIGS. 14 and 14 b are a cross-sectional views of the embodiment of FIG.5; and

FIGS. 15 and 15 a are cross-sectional views illustrating alternativeembodiments of a prosthesis according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Before explaining the present invention in detail, it should be notedthat the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The illustrative embodiments ofthe invention may be implemented or incorporated in other embodiments,variations and modifications, and may be practiced or carried out invarious ways. For example, although the present invention is describedin detail as it relates to implantable prostheses for repairingumbilical hernias, it is to be understood that such devices can readilybe used for repairing various other soft tissue or muscle wall defects,including but not limited to trocar site punctures, small ventralhernias etc.

Referring now to FIGS. 1-8 and 14 a-b, a preferred embodiment of aprosthesis of the present invention will now be described in detail.Prosthesis 100 is a composite prosthesis formed from multiple elementsas shown in FIG. 1, including a first composite structure 115, areinforcing element 116 (together the “first reinforced structure”), anda second structure 140. The first structure 115 has a central portion115 a sized and shaped to cover at least a portion of the tissue ormuscle wall defect, and preferably first and second extension portions126, 127 extending laterally outward from opposite sides of the centralportion.

The first structure further includes a patch member 102 having a topside 101 and a bottom side 103, and a patch portion 104 corresponding insize and shape to central portion 115 a. In the illustrated embodiment,patch portion 104 is substantially circular in overall shape, having adiameter D of approximately 4.3-6.4 cm, which is suitable for repair ofa typical umbilical hernia defect. Extending laterally outwardly fromopposite sides 105, 106 of the patch portion are first 107 and second108 extension portions corresponding substantially in size and shape tofirst and second extension portions 126, 127. The patch memberpreferably comprises a non-absorbable mesh structure, such as thePROLENE™ Soft Mesh, which is a knitted, non-absorbable polypropylenemesh manufactured by Ethicon, Inc. of Somerville, N.J., although anysuitable biocompatible material may be used.

Positioned adjacent the top 101 and bottom 103 sides of the patchportion are first 109 and second 110 film layers respectively,preferably comprised of an absorbable material such as polydioxanone. Ina preferred embodiment, the first layer 109 is approximately 0.0002inches thick and the second layer 110 is approximately 0.0008 inchesthick. Positioned adjacent a bottom side 111 of the second film layer110 is a third layer 112, that also preferably is comprised of anabsorbable material. The absorbable material may be oxidized regeneratedcellulose (ORC), having a composition such as that manufactured and soldby Ethicon, Inc. under the name INTERCEDE™. The size and shape of thefirst, second, and third layers are substantially similar to that of thepatch portion 104, and may mimic the patch member as a whole asillustrated for the first and second film layers. The components arealigned as shown in FIG. 1, and then secured together in any suitablemanner, such as by bonding by heating the assembly to a temperature ofapproximately 130 degrees Celsius for approximately 30 seconds, to formthe first structure 115. When implanted, the third layer 112 provides abioresorbable layer that physically separates and protects thenon-absorbable polypropylene mesh from underlying tissue and organsurfaces during the wound-healing period to minimize tissue attachmentto the polypropylene mesh.

While the illustrative embodiment described for structure 115 disclosesa composite structure that provides an implant with a barrier surface onone side of the implant while providing a second surface intended toincorporate into the parietal wall, alternate monolithic layers areenvisioned which incorporate both functions into one structure. Oneexample of such a monolithic structure is produced by W.L. Gore &Associates, a Delaware Corporation, and sold as GORE DUALMESH®.

After forming the first structure 115, the ends of the first and secondextension portions 126, 127 respectively are folded over and sewn orotherwise secured in place to form looped elements 120, 121 as bestshown in FIG. 2. A reinforcement element 116 (described in detailbelow), preferably having a substantially similar size and shape as thepatch portion 104, is then aligned adjacent a top surface 113 of thefirst structure 115 as shown in FIG. 2. The first and second extensionportions 126, 127 of the first structure are extended around acircumferential edge 117 of the reinforcement element 116 and over thetop side 118 to a central portion 119 of the reinforcing element asshown in FIG. 3.

Referring back to FIG. 1, the preferred embodiment of the prosthesisalso includes a second structure 140 having an outer periphery 143 and acentral region 143 a. The second structure further includes a secondmesh layer 130, third and fourth film layers 132, 134 positionedadjacent top bottom and top 133, 135 sides thereof, and a separatestiffening element 136 in the central region, preferably a film ring,having an outer diameter less than that of film layers 132, 134 andpositioned adjacent a bottom side 137 of the third 132 film layer. Thesecond mesh layer 130 is preferably made of a synthetic, absorbablematerial, such as VICRYL™ Mesh, which is prepared from polyglactin 910and also manufactured and sold by Ethicon, Inc. of Somerville, N.J. Thethird and fourth film layers and film ring are preferably comprised ofpolydioxanone. The layers are aligned as illustrated and bonded togetherto form a second structure 140 having a top side 140 a and a bottom side140 b. Alternatively, this composite structure may be replaced be amonolithic layer that is formed of varying stiffness regions with thecentral portion having significantly greater stiffness than the regionsnear the perimeter of the layer.

The first reinforced structure 129 shown in FIG. 3 and the secondstructure 140 are then aligned as shown in FIG. 4 so that the first andsecond loops 120, 121 extend through first and second openings 142, 144through the second structure 142 as shown in FIG. 5, and then bonded(i.e., via ultrasonic welding), fused, sewn, or otherwise joinedtogether substantially only around their respective outer peripherieswith the exception of extension portions 126, 127 as described below. .Finally, additional grasping elements 150, 151, such as an ETHIBOND™polyester suture or the like (also manufactured by Ethicon, Inc.), maybe inserted through the first and second loops 120, 121 as shown in FIG.6.

As indicated, film ring 136 is bonded to the second structure 140, butis not bonded to the first reinforced structure. Further, the first andsecond extension portions 126, 127 are coupled to the film ring 136 ofthe second structure and are not otherwise secured to the firstreinforced structure other than around the peripheral edge. Thisconfiguration is advantageous in that it enables a centralized forceexerted on the first and second loops 120, 121 to be distributed to thefilm ring 136, and thus distributed substantially uniformly through thesecond structure 140 and ultimately to the outer periphery 146 of theprosthesis, which is reinforced by the outer circumferential ring 180 ofthe reinforcement element. This distribution of forces is illustrated inthe cross-sectional view of FIG. 14 b, where P denotes the pulling forceexerted on the loops 120, 121 and p denotes the resulting forcesexperienced by the prosthesis (as opposed to FIG. 14 a illustrating thedevice with no pulling forces being exerted on it). This substantiallyuniform distribution of centralized forces to the outer periphery of theimplant provides significant improvements over known devices in theability to avoid point stresses and potential damage to the implant atthe attachment point(s) of the straps, and to implant and correctlyplace the prosthesis.

The effective redistribution of forces as described above is achievedwith the described and illustrated preferred embodiment, but can also beachieved in various other alternative embodiments so long as centralstraps or other pulling elements are secured to a centrally reinforcedsecond structure that is coupled to the first reinforced structuresubstantially only about its peripheral edge. For example, an alternateembodiment could include a single 120 a or separate straps that arecoupled or secured by any suitable means to a ring element 136 a of asecond structure 140 a as shown in FIG. 15, or may utilize one or morepulling elements 120 b, 121 b or grasping means attached to asubstantially solid central element 136 b as shown in FIG. 15 a. Bothembodiments enable the distribution of loading during tensioning,however the embodiment illustrated in FIG. 15 a provides a threedimensional central portion 137 a capable of at least partially fillingthe defect in the fascial plane.

Referring now to FIGS. 7 and 8, the reinforcing element 116 serves toreinforce the implant, and maintain its proper substantially flatorientation covering the defect within the patient's body. Thereinforcing element must be flexible enough to allow it to be collapsedfor passage through the incision and defect, but resilient enough toresume the substantially flat configuration once properly placed. Theelement should control, in part or in whole, the direction of strainwhen subjected to a radial compressive force. Additionally, thereinforcing element must not inhibit tissue incorporation into thetissue support layer and should provide means for the healing tissue topass through to the tissue support layer. The resilient elementdescribed and illustrated herein has been found particularly suitablefor these purposes, and its preferred three-dimensional configurationgreatly improves resistance to collapsing or buckling of the implantafter placement.

The three dimensional form provides the additional benefit ofcontrolling the direction of strain of the implant during placement.During installation and following insertion of the device through thedefect , the first and second loops 120, 121 are pulled on by thesurgeon to ensure a proper and tight fit of the implant relative to thedefect. During this application of tension to the straps, the force fromthe user is distributed from the center of the device uniformly to theperimeter of the reinforcing layer thereby creating a radial compressiveload in the reinforcing layer. As this compressive loading increases onthe reinforcing layer, the strain in the reinforcing layer is directedtowards the center of the device and, in the preferred direction, awayfrom the parietal wall. This controlled direction of strain results inthe perimeter of the device conforming tightly to the parietal wall dueto the increased strain in the third dimension of the form or “cupping”of the reinforcing layer. This improved compliance of the perimeter ofthe device prevents the user from collapsing the device in a directionthat would cause exposure of the side of the device to the viscera.While the specific embodiment incorporates a semi-toroidal shape, itshould be noted that any symmetrical three dimensional form, such as aspherical shape, would provide the same functional benefit duringinstallation. As shown in the side view of FIG. 8, the reinforcingelement preferably has a three-dimensional (“three-dimensional” meaninghaving a third dimension other than simple thickness of a planarstructure), somewhat toroidal shape, with an outer circumferential ring180 of the element lying substantially in a first horizontal plane andan inner circumferential ring 182 lying substantially in a secondhorizontal plane. Spoke like elements 184 extend therebetween, and inthe illustrated embodiment, an intermediate circumferential ring 186 ispositioned between the outer circumferential ring 180 and the innercircumferential ring 182. The reinforcing element is preferably made ofan absorbable material, such as polydioxanone, with a thickness ofapproximately 0.015 inch which renders its stiffness greater than thatof the first or second structures 115, 140. In a preferred embodiment,it may further include one or more rib-like elements 188 extendinglongitudinally along portions of the spoke-like elements 184. The ribelements further reinforce and provide stability to the implant andprevent permanent inversion of the formed shape from transientcompression perpendicular to the plane of the center portion of thethree dimensional reinforcing layer. The three-dimensional geometry andconfiguration of the reinforcing element has proven to be superior overtwo-dimensional geometries in achieving an optimum combination offlexibility, rigidity, resistance to buckling, and controlling thedirection of strain for the above-described application.

FIGS. 9-13 illustrate various steps of a method for implanting aprosthesis according to the present invention. The skin and tissue inthe area of the defect is dissected to provide access to the surgicalsite. Preferably, the hernia sac is exposed as illustrated in FIG. 9,with the sac divided and contents inverted as shown in FIG. 10. Thepatch 100 is folded over with the side containing the straps on theinterior of the fold, and the exposed ORC fabric layer 112 on theexterior of the fold as shown in FIG. 11. The patch 100 is thendelivered into the surgical site through the incision 200. This may bedone in any suitable manner, including with or without the use of acannula or trocar to facilitate its passage. When the patch is fullywithin the intra-peritoneal space, the patch is released from its foldedconfiguration so that it resiliently resumes its original, substantiallyflat configuration. Proper positioning against the internal viscera inthe substantially flat configuration (with the ORC fabric layer 112facing the internal viscera) is further facilitated by pulling slightlyon the grasping elements 150, 151. Following suitable placement, loops120, 121 are secured to the anterior fascia as shown in FIG. 12, leavingthe implanted patch as shown in FIG. 13.

It will be apparent from the foregoing that, while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

1-45. (canceled)
 46. An implantable prosthesis for repairing orreinforcing a tissue or muscle wall defect, comprising: a firstbiocompatible structure having a central portion sized and shaped tocover at least a portion of the tissue or muscle wall defect and havinga top side, and a bottom side, the first structure having a stiffness; areinforcement element positioned adjacent the top side of the centralportion and having a top side, a bottom side, and an outercircumferential edge; a second biocompatible structure having a top sideand a bottom side, the second structure having a stiffness; a ringmember element mounted to the second structure, and, at least one strap,each strap mounted proximate to the ring member and extending away fromthe prosthesis, wherein the first structure and the second structure arecoupled to one another at least about a part of their respective outerperipheries.
 47. The prosthesis according to claim 46, wherein thereinforcement element increases the stiffness of the first and secondstructures.
 48. The prosthesis according to claim 46, wherein thereinforcement element further comprises an outer circumferential ringand an inner circumferential ring and a plurality of connecting elementsextending there between.
 49. The prosthesis according to claim 46,wherein the reinforcement element has a three-dimensional shape.
 50. Theprosthesis according to claim 49, wherein the reinforcement elementfurther comprises an outer circumferential ring, an innercircumferential ring, and a plurality of connecting elements extendingthere between, and wherein the outer circumferential ring liessubstantially in a first horizontal plane and the inner circumferentialring lies substantially in the first horizontal plane.
 51. Theprosthesis of claim 50, wherein the inner circumferential ring lies in asecond horizontal plane different from the first horizontal plane. 52.The prosthesis according to claim 50, further comprising at least onerib-like element extending from at least one connecting element out of aplane defined by the connecting elements.
 53. The prosthesis accordingto claim 52, wherein the at least one rib-like element is alignedlongitudinally along a length of the at least one connecting element.54. The prosthesis according to claim 46, wherein the first structurefurther comprises: a patch member comprised of a non-absorbable mesh;and first and second bioabsorbable polymeric film layers positionedadjacent to the top and bottom sides of the patch member respectivelyand secured thereto.
 55. The prosthesis according to claim 54, whereinthe patch member is comprised of polypropylene and the first and secondfilm layers are comprised of polydioxanone.
 56. The prosthesis accordingto claim 54, wherein the first structure further comprises an additionallayer positioned adjacent to a bottom side of the second film layer andsecured thereto.
 57. The prosthesis according to claim 56, wherein theadditional layer is comprised of a bioabsorbable material.
 58. Theprosthesis according to claim 57, wherein the third layer is comprisedof oxidized regenerated cellulose.
 59. The prosthesis according to claim54, wherein the second structure further comprises a mesh layer, andthird and fourth film layers positioned adjacent top and bottom sidesrespectively of the mesh layer.
 60. The prosthesis according to claim59, wherein the mesh layer and third and fourth film layers of thesecond structure are comprised of bioabsorbable materials.
 61. Theprosthesis according to claim 60, wherein the mesh layer is comprised ofpolyglactin and the third and fourth film layers are comprised ofpolydioxanone.
 62. The prosthesis of claim 46, wherein the ring memberelement comprises a bioabsorbable polymer.
 63. The prosthesis of claim46, wherein the reinforcing element has a three-dimensional shape. 64.The prosthesis of claim 46, wherein the reinforcing element comprises abioabsorbable polymer.
 65. The prosthesis of claim 55, wherein theadditional layer separates underlying viscera from the prosthesis afterimplantation.
 66. An implantable prosthesis for repairing or reinforcinga tissue or muscle wall defect, comprising: a first biocompatiblestructure having a central portion sized and shaped to cover at least aportion of the tissue or muscle wall defect and having a top side, abottom side, and an outer periphery, the first structure having astiffness; a reinforcement element positioned adjacent the top side ofthe central portion and having a top side, a bottom side, and an outercircumferential edge; a second biocompatible structure having a topside, a bottom side and an outer periphery, the second biocompatiblestructure having a three-dimensional central section, the secondstructure having a stiffness; a central element mounted proximate to thesecond biocompatible structure in the central section; and, at least onepulling element mounted proximate to the central element and extendingout from the prosthesis, wherein the first biocompatible structure andthe second biocompatible structure are coupled to one another at leastabout a part of their respective outer peripheries.
 67. The prosthesisof claim 66, wherein the three-dimensional central section has a shapeselected from the group consisting of conical, hemispherical,frustoconical, parabolic, cylindrical, box-like, and the like.
 68. Theprosthesis of claim 66, wherein the three-dimensional central section ofthe second biocompatible structure is capable of at least partiallyfilling a tissue defect in the fascial plane.
 69. The prosthesisaccording to claim 66, wherein the reinforcement element increases thestiffness of the first and second structures.
 70. The prosthesisaccording to claim 66, wherein the reinforcement element furthercomprises an outer circumferential ring and an inner circumferentialring and a plurality of connecting elements extending there between. 71.The prosthesis according to claim 66, wherein the reinforcement elementhas a three-dimensional shape.
 72. The prosthesis according to claim 71,wherein the reinforcement element further comprises an outercircumferential ring, an inner circumferential ring, and a plurality ofconnecting elements extending there between, and wherein the outercircumferential ring lies substantially in a first horizontal plane andthe inner circumferential ring lies substantially in the firsthorizontal plane.
 73. The prosthesis of claim 72, wherein the innercircumferential ring lies in a second horizontal plane different fromthe first horizontal plane.
 74. The prosthesis according to claim 72,further comprising at least one rib-like element extends outwardly fromat least one of the plurality of connecting elements
 76. The prosthesisaccording to claim 74, wherein the at least one rib-like element isaligned longitudinally along a length of the at least one connectingelement.
 77. The prosthesis according to claim 66, wherein the firststructure further comprises: a patch member comprised of anon-absorbable mesh; and first and second bioabsorbable polymeric filmlayers positioned adjacent to the top and bottom sides of the patchmember, respectively.
 78. The prosthesis according to claim 77, whereinthe patch member is comprised of polypropylene and the first and secondfilm layers are comprised of polydioxanone.
 79. The prosthesis accordingto claim 77, wherein the first structure further comprises an additionallayer positioned adjacent to a bottom side of the second film layer. 80.The prosthesis according to claim79, wherein the additional layer iscomprised of a bioabsorbable material.
 81. The prosthesis according toclaim 79, wherein the third layer is comprised of oxidized regeneratedcellulose.
 82. The prosthesis according to claim 66, wherein the secondstructure further comprises a mesh layer, and third and fourth filmlayers positioned adjacent top and bottom sides respectively of the meshlayer and secured thereto.
 83. The prosthesis according to claim 82,wherein the mesh layer and third and fourth film layers of the secondstructure are comprised of absorbable polymeric materials.
 84. Theprosthesis according to claim 82, wherein the mesh layer is comprised ofpolyglactin and the third and fourth film layers are comprised ofpolydioxanone.
 85. The prosthesis of claim 66, wherein the centralelement comprises a bioabsorbable polymer.
 86. The prosthesis of claim66, wherein the reinforcing element has a three-dimensional shape. 87.The prosthesis of claim 66, wherein the reinforcing element comprises abioabsorbable polymer.
 88. The prosthesis of claim 79, the additionallayer separates underlying viscera from the prosthesis afterimplantation.